What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, as well as pharmacological and dietary-supplement treatments. Behavioral and educational interventions generally have minimal side effects but can be intensive and require significant time and effort from both the child and caregivers. Pharmacological treatments, although not approved for core symptoms of ASD, are sometimes used to manage associated symptoms like irritability, hyperactivity, and anxiety. These medications can have side effects such as weight gain, drowsiness, and gastrointestinal issues. Dietary supplements, like melatonin for sleep disturbances, are generally well-tolerated but can occasionally cause headaches, dizziness, or daytime drowsiness.

What prior FDA approvals exist?

The FDA has approved two medications specifically for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These antipsychotic drugs help manage symptoms such as aggression, self-injury, and severe tantrums. While these medications do not address the core symptoms of ASD, they are part of a broader treatment strategy that includes early screening, diagnosis, and behavioral interventions, similar to the approach studied in the Early Diagnosis and Referral Model (EDRM). Comprehensive early intervention remains crucial for improving long-term outcomes in children with ASD.

What other types of research exist?

Promising, novel alternatives to the Early Diagnosis and Referral Model (EDRM) for ASD patients include: 1) The Early Start Denver Model (ESDM), which combines early diagnosis with early intervention to positively influence the natural history of ASD. 2) The Rapid Interactive Screening Test for Autism in Toddlers (RITA-T), which improves ASD detection in underserved communities. 3) Systems-based innovations funded by the National Institute of Mental Health, designed to improve access to early screening, diagnosis, and treatment. 4) The use of machine learning for behavioral distinction between autism and ADHD, which can aid in preliminary risk evaluation and pre-clinical screening.

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EDRM for Autism

N/A

Recruiting

Led By Allison Schwartz, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Must not have

Children above the age of 33 months at the time of the referral will be excluded as the current EDRM protocol has not been developed in this phase of piloting for individuals over this age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until the end of the study (approximately one year)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method to diagnose autism in young children using online tools. It focuses on families with high-risk toddlers. The method involves trained psychologists conducting evaluations via telehealth to provide timely diagnoses.

Who is the study for?

This trial is for families with children aged 16-30 months at risk for autism, referred by specific BCW districts. Participants need internet access, exposure to English, and basic English skills. Children must score ≥8 on the MCHAT-R and be referred by 33 months of age.

What is being tested?

The EDRM protocol is being tested to see if it's effective in diagnosing autism early in kids identified as high-risk in a public health service program. The study will collect data before and after implementing EDRM to assess its success.

What are the potential side effects?

Since this trial involves an evaluation of a diagnostic model rather than a medical intervention, there are no direct side effects like those associated with medications or treatments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My child is not older than 33 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until end of the study (approximately one year)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until end of the study (approximately one year)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until end of the study (approximately one year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants consented in the Early Diagnostic Response Model (EDRM) study

Number of participants referred to the Early Diagnostic Response Model (EDRM)

Number of participants that completed the Early Diagnostic Response Model (EDRM) study

+2 more

Secondary study objectives

BCW provider(s) Early Intervention Coordinator satisfaction with EDRM pilot survey

BCW provider(s) Service Coordinator satisfaction with EDRM assessment survey

Number of families screened high risk for ASD and referred for an evaluation

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Families with children enrolled in BCW with suspected diagnosis of autismExperimental Treatment1 Intervention

Post-consent, families with children between 16-33 months will receive a link to complete the EAC Developmental History Survey on REDCap and a link to complete parent/caregiver questionnaires about developmental and/or adaptive information. Then, the family will be assigned to a clinician for the autism assessment and scheduled their assessment and feedback session (one week later).

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) focus on early behavioral and educational interventions. These treatments work by creating structured and supportive teaching environments, offering individualized programming, and providing intensive therapy sessions that target core symptoms such as social communication deficits and repetitive behaviors. Key mechanisms include a high staff-to-student ratio, family involvement, and ongoing program evaluation to adapt to the child's needs. These approaches are crucial as they offer early and intensive support, which is linked to improved long-term outcomes for children with ASD.

Research-Based Intervention (RBI) for Autism Spectrum Disorder: Looking beyond Traditional Models and Outcome Measures for Clinical Trials.What are we targeting when we treat autism spectrum disorder? A systematic review of 406 clinical trials.Commentary: Randomized controlled trials in autism spectrum disorder: state of the field and challenges for the future.